Apparatus for sealing a puncture in a blood vessel

ABSTRACT

An apparatus for sealing a puncture in a blood vessel is disclosed having a tissue-confining device for compressing tissue in the vicinity of the puncture, which longitudinally extends between a proximal end and a distal end and is connected to an adjustable artery clamp for controllably applying pressure, such as by a fluid circuit, onto the blood vessel, so as to reduce the hemostatis time. The artery clamp comprises in a preferred embodiment a proximal plunger and a distal plunger positioned upstream and downstream, respectively, to the puncture. The apparatus is also suitable for treating a pseudoaneurysm.

FIELD OF THE INVENTION

The present invention is concerned with an apparatus for facilitatingsealing of a puncture in a blood vessel during a medical procedure, anda method utilizing the apparatus. More particularly the invention isconcerned with an apparatus suitable for cooperation in conjunction withsuch procedures in which a puncture is formed by a guide sheathintroduced into the blood vessel.

BACKGROUND OF THE INVENTION

During several surgical procedures, for example in treatment of vasculardiseases, it is common practice to invade a blood vessel and introduce atreating or diagnostic device, e.g. balloons or various types of stentsto operate on walls of the arteries, plaque removing devices,observation and flow diagnostic instruments, etc.

During such procedures, a blood vessel is punctured so as to allowintroduction of the instrument through the artery and then maneuver itto the required site of operation. This is carried out in practice byintroducing a guide sheath often, through which the instrument can thenbe easily maneuvered to the site of interest.

A problem occurs once the procedure is complete and the guide sheath hasthen to be removed, when the percutaneous puncture bleeds. Bleeding mayresult in hematoma or in severe cases to malfunction of critical organsand even death. Such bleeding is stopped, by a most common method, bysimply applying pressure on to the puncture site by a medically trainedperson for a sufficiently long period of time until hemostasis takesplace to spontaneously seal the puncture and stop the bleeding.

In cases of puncturing the femoral arteries, the required time may be aslong as about 45 minutes or more and in some cases re-bleeding occurs ifthe patient is not in rest. Some devices have been proposed forfacilitating applying pressure over a blood vessel, some of whichparticularly for the purpose of sealing a punctured blood vessel.Examples of such devices are disclosed in U.S. Pat. Nos. 3,625,219;3,884,240; 4,557,262; 5,304,186; and 5,304,201. The devices disclosed inthese Patents merely apply mechanical pressure to the blood vessel anddo not facilitate use of sealing and flow monitoring devices.

A variety of methods and devices have been suggested for replacing thetraditional methods disclosed above, some of which involve introducingchemical compounds which act as hemostatic catalysts or as adheringagents, whilst others aim at introducing various forms of pluggingmembers into the puncture.

The following is a list of prior art patents disclosing devices andmethods for sealing punctured blood vessels, all of which being directedto plug-type devices: U.S. Pat. Nos. 4,705,040 4,890,612, 4,929,246,5,108,420, 5,342,393, 5,350,399, 5,391,183, 5,613,974, 5,810,884,5,861,003, 5,957,952, 5,984,950, 6,007,563 and WO98/31287.

It is an object of the present invention to provide a novel andinventive apparatus for facilitating effective sealing of a puncture oran incision formed by the introduction of a guide sheath in a bloodvessel. A further object of the invention is to provide a methodutilizing this apparatus.

It is an additional object of the present invention an apparatus andmethod for reducing the hemostasis time for a puncture formed by theintroduction of a guide sheath in a blood vessel, relative to the priorart.

SUMMARY OF THE INVENTION

According to a broad aspect of the present invention, an apparatus isprovided for entrapping tissue over a punctured blood vessel, in thevicinity of the puncture, prior to withdrawal of the guide sheath, suchthat effective axial pressure may then be applied at the puncture site,to thereby cause partial or total occlusion of the blood vessel,resulting in that the coagulation process (hemostasis) is more rapid.The apparatus also facilitates easy introduction of sealing means.

According to the present invention, an apparatus for sealing a puncturein a blood vessel comprises a tissue-confining device longitudinallyextending between a proximal end and a distal end; at least a proximalplunger positioned adjacent to said proximal end for adjustably applyingaxial pressure on the blood vessel; said tissue-confining device beingconnected to an adjustable artery clamp for adjustably applying pressurein an axial direction.

The term artery clamp, as referred to herein, denotes a device and astructure that supports said device, which allows for the compressing ofa blood vessel, particularly an artery, by an element-hereinafterreferred to as a “plunger”—that is pressed onto said blood vessel. Anadjustable artery clamp denotes an artery clamp that may be displaced ina controllable fashion, e.g. wherein the structure is axially andtransversally displaceable relative to the puncture site and thepressing elements are axially and longitudinally displaceable relativeto the structure.

The term tissue-confining device, as referred to herein, denotes adevice with an open area bounded by its frame, which is externallyplaced over a limb of a patient and above a puncture site of the bloodvessel, and is so configured that following the application of an axialforce to said tissue-confining device it entraps, within said open area,and compresses tissue in the vicinity of the punctured blood vessel. Thedepth to which the tissue in the vicinity 6f the punctured blood vesselis compressed depends on the magnitude of said axial force and therigidity of said tissue. The tissue-confining device is thereforefixated with respect to said blood vessel, and furthermore, reduces thedistance between the puncture site and the skin protecting said puncturesite. Blood flow through said blood vessel is not necessarilyconstricted as said tissue in the vicinity of the punctured blood vesselis compressed.

As referred to herein, “axial” means a direction from a plunger to ablood vessel, “longitudinal” means a direction parallel to the axis of ablood vessel and “transversal” means a direction perpendicular to thelongitudinal direction. “Proximal” means towards the upstream side ofblood flow and “distal” means towards the downstream side of blood flow,relative to a puncture site.

A tissue-confining device, according to an aspect of the invention,comprises two parallel, longitudinally extending bars, interconnected ator adjacent their respective proximal and/or distal ends by arcuateconnecting members, said tissue-confining device suitable forcompressing tissue in the vicinity of a punctured blood vessel and forbeing connected to an adjustable artery clamp, which is adapted foradjustably applying pressure in an axial direction onto a blood vessel.

In accordance with a particular embodiment, the apparatus furthercomprises a distal plunger positioned downstream of said proximalplunger, said distal plunger adapted for applying axial pressure ontothe blood vessel, essentially above the puncture site, after withdrawalof the guide sheath.

According to one embodiment, axial pressure is applied by means selectedfrom the group of mechanical means, hydraulic means, pneumatic means andelectrical means.

In one aspect, axial pressure is generated by means of a fluid circuitcomprising an actuator, a cylinder in which fluid is pressurized, aconduit for said fluid, and a junction by which said cylinder and saidconduit are in fluid communication with one another, fluid beingflowable within said fluid circuit to or from a plunger.

Preferably, the apparatus further comprises means for adjusting theangular orientation, with respect to the artery clamp, of a point fromwhich pressure is applied to the blood vessel.

According to one embodiment, the tissue-confining device is positionedupstream and adjacent the point of penetration of the guide sheath intothe body.

According to another embodiment, the guide sheath is removablyattachable to the tissue-confining device.

Noting that the tissue-confining device is fitted with a plunger forapplying pressure precisely over the puncture of the blood vessel, it isthus useful in preventing the formation of a pseudoaneurysm, (which isan encapsulated hematoma communicating with an artery, caused by anincomplete sealing of the artery and surrounding tissue after removal ofan guide sheath).

Another aspect of the present invention is concerned with an apparatusfor controllably applying pressure onto a blood vessel, comprising:

a) at least one axially and longitudinally displaceable plunger forapplying pressure onto a blood vessel;

b) means for positioning said at least one plunger to a first locationabove a skin target and directly over said blood vessel;

c) means for generating a controllable force; and

d) means for transmitting said controllable force to said at least oneplunger in such a way that said at least one plunger is axiallydisplaceable from said first location to a second location in contactwith said skin target and directly above said blood vessel, and that acontrollable and known pressure is applied by said at least one plungeronto said skin target,

said pressure being controllable to such a degree so as to reduce bloodflow velocity within said blood vessel.

The means of generating a controllable force is selected from the groupof hydraulic means, pneumatic means and electric means.

Another aspect of the present invention is concerned with a method forsealing a puncture in a blood vessel caused by an guide sheath, saidmethod comprising the following steps:

-   -   a) confining the blood vessel and fixedly positioning it;    -   b) applying an axial force on the blood vessel upstream of the        puncture, so as to cause partial or total occlusion thereof; and    -   c) withdrawing the guide sheath.

The term partial occlusion denotes the state at times referred to asstenosis, i.e. where the blood vessel particularly an artery) is onlypartially occluded, e.g. 50% or more, whereby vibration/pulsation of theartery wall ceases, resulting in the temporary disappearance of thediastole and systole or in reduced blood flow velocity at an arterialpuncture site. Partial occlusion reduces the hemostasis time. Indicationrelating to the extent of occlusion is obtained by measuring bloodpressure or blood flow velocity, before and after applying axialpressure to the blood vessel (blood pressure before applying axialpressure may be measured also at the arm of the patient, as known perse), or by measuring the pulses of blood flow within a blood vesseldistal to the puncture site.

According to an embodiment of the invention, the method furthercomprises a step d) wherein axial pressure is applied directly over thepuncture.

According to another embodiment, prior to step c) a sealing plug isintroduced and placed over the puncture. In one aspect, the sealing plugis slid over the guide sheath, is downwardly displaced, and introducedinto the blood vessel at the puncture site.

A sealing plug used in conjunction with the present invention comprisesa blood vessel engaging portion for bearing against the boundaries ofthe puncture, and a sealing portion slidably received over the guidesheath; said sealing portion being spontaneously sealable uponwithdrawal of the guide sheath; the sealing plug being displaceable by apusher member.

In one aspect, a sealing plug connected to the bottom of a telescopingplunger is slidable about the outer wall of the guide sheath. Thetelescoping plunger is retracted or extended by means selected from thegroup of mechanical means, hydraulic means, pneumatic means andelectrical means.

Another aspect of the present invention is concerned with a method forsealing a puncture in a blood vessel caused by a guide sheath, saidmethod comprising the following steps:

-   -   a) axially positioning over the blood vessel, at the vicinity of        the puncture, an apparatus comprising a tissue-confining device        and a proximal plunger positioned upstream of the puncture, said        tissue-confining device connected to an adjustable artery clamp        device;    -   b) adjustably applying an axial force at the vicinity of the        puncture by said artery clamp device, to thereby confine the        blood vessel;    -   c) adjustably applying axial pressure on the blood vessel by        said proximal plunger, to reduce the blood pressure and blood        flow in the blood vessel;    -   d) withdrawing the guide sheath.

Another aspect of the present invention is concerned with a method fortreating a pseudoaneurysm, said method comprising the following steps:

a) detecting a pseudoaneurysm and a pseudoaneurysm neck between anartery and said pseudoaneurysm;

b) confining said pseudoaneurysm or pseudoaneurysm neck;

c) fixedly positioning said pseudoaneurysm or pseudoaneurysm neck;

d) applying a controllable axial force on said artery upstream to apuncture which resulted in said pseudoaneurysm, so as to cause partialor total occlusion within said artery; and

e) applying a controllable axial force on said pseudoaneurysm neck,thereby inducing a blood clot within said pseudoaneurysm.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a front isometric view of an apparatus according to anembodiment of the present invention;

FIG. 2 is a detailed isometric view of a tissue-confining deviceaccording to an embodiment of the invention, also showing a portion ofthe artery clamp device;

FIG. 3 is a side view of the apparatus illustrated in FIG. 1, in useduring a medical procedure, over a patient's limb;

FIG. 4 illustrates the device of FIG. 2 used in conjunction with atransducer of an imaging device;

FIGS. 5A to 5G illustrate variations of a tissue-confining device inaccordance with embodiments of the present invention;

FIGS. 6A and 6B are an isometric and a side view, respectively, of atissue-confining device according to still an embodiment of theinvention, also showing a portion of the artery clamp device, in tworespective positions;

FIG. 7A is an isometric view of a puncture sealing plug for use inconjunction with the present invention;

FIG. 7B illustrates the sealing plug of FIG. 7A fitted with anintroducer therefore;

FIG. 8 is a front isometric view of a hydraulically powered artery clampdevice, according to another embodiment of the invention;

FIG. 9 is a rear isometric view of the embodiment of FIG. 8;

FIGS. 10A-C are isometric views of three configurations of atissue-confining device, respectively;

FIG. 11A is a vertical cross sectional view of a portion of a hydrauliccircuit according to one embodiment of the invention, showing anactuator and a junction;

FIG. 11B is a perspective view of the actuator of FIG. 11A;

FIG. 12 is a front isometric view of an artery clamp device according tothe invention, showing the position of a tissue-confining devicerelative to an arterial puncture site;

FIGS. 13A and 13B are a side and a vertical cross sectional view of aplunger casing, showing one variation of a pressure pad;

FIG. 14 is a front isometric view of an artery clamp device according tothe invention, showing another variation of a pressure pad;

FIGS. 15A and 15B are side isometric views of a retracted and extendedtelescoping plunger, respectively, by which a sliding plug is displacedalong an guide sheath;

FIG. 16 is a front isometric view of a hydraulically displaceablesealing plug; and

FIG. 17 is a front isometric view of a mechanically displaceable sealingplug.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Attention is first direct to FIG. 1 which is an overall view of anapparatus in accordance with the present invention generally designated20, comprising an adjustable artery clamp device designated 22 and atissue-confining device generally designated 24.

Artery clamp device 22 comprises a base plate 28 from which verticallyextends an adjustable arm 30 fitted at a free end thereof with anattachment bracket 32.

Arm 30 may be adjusted as far as the height of adjustment bracket 32from the base plate 28 and the transversal distance of the adjustablebracket 32 from the essentially vertical leg portion of the arm 30.

An artery clamp device in accordance with the invention may be anysuitable such device in which its free end may be displaced bothvertically and horizontally to correspond with different sizes andlocations over a patient's limb and for applying suitable axialpressure. This may be obtained by different mechanical, hydraulic,pneumatic or electrical means as known per se.

A pressure indicator 38 is mounted on the arm 30 for indicating thepressure applied at the free end thereof Such a pressure indicator maybe associated with a strain gauge or pneumatic means, as known per se.

Tissue-confining device 24 is pivotally attached to the adjustmentbracket 32 of the artery clamp device at 31 and the angular position ofthe tissue-confining device may be changed with respect to the arteryclamp device by release knob 33 (see also FIG. 2). The angularorientation of the tissue-confining device with respect to the arteryclamp is fixable.

Further attention is now directed to FIG. 2 illustrating in more detaila particular embodiment of a tissue-confining device generallydesignated 40. The device in the present embodiment is a frame-likemember comprising two longitudinally extending bars 42 and 44, thelength of which may range from 20-90 mm, connected to one another at aproximal end 46 and a distal end 48. The term proximal end correspondswith the position of the device during the course of operation, with anupstream side of a blood vessel at the patient's limb.

As noted, the bars 42 and 44 are connected to one another by arespective proximal connecting bar 52 and a distal connecting bar (notseen in FIG. 2), both being arcuate in a concave manner. Longitudinallyextending bars 42 and 44 and the connecting bars define an open area 56formed therebetween.

Proximal plunger 60 fitted over the proximal connecting bar 52 isadapted for applying axial pressure in the direction of arrow 62. Theplunger 60 may be temporarily depressed by applying pressure over tab 64or may be fixed at any axial extent by retention nut 66. The purpose ofplunger 60 will become apparent hereinafter.

A distal plunger 70 is slidably and pivotally mounted on alongitudinally extending rod 72 and its angular and longitudinalpositions may be securely fixed by means of a spring-biased fixationknob 74. Plunger 70, similarly to plunger 60, may be temporarilydepressed or may be fixedly retained at any axial extent by means ofretention nut 78. The purpose of this plunger will also become apparenthereinafter.

Further attention is now directed to FIG. 3 illustrating how anapparatus 20 in accordance with the present invention is in actual use.The base plate 28 of the artery clamp device 22 is placed under thepatient's limb L (typically a thigh), for which the medical procedure isto be carried out. The arm 30 of the artery clamp device is thenadjusted such that the tissue-confining device 24 tightly bears over thelimb L at the site of puncture, and applies axial pressure thereto, suchthat a portion of tissue becomes confined between the bars 42 and 44 ofthe tissue-confining device and deforms to project into the open area 56(FIG. 2). Tissue-confining device 24 is therefore positioned and fixatedin relation to blood vessel BV, such that the latter longitudinallyextends through open area 56, passing directly underneath plunger 60. InFIG. 3, a guide sheath GT is received within the blood vessel BV. Thepressure applied onto the limb L by plunger 60 is monitored by thepressure indicator 38.

The embodiment of FIG. 4 illustrates a tissue-confining device 40,identical with that illustrated in detail in FIG. 2, while distalplunger 70 is shifted away from the open area 56 so as to clear thespace, allowing for the accommodation of a transducer 80 of an imagingdevice in a fixed manner. The imaging device may be an ultrasounddevice, such as an X-ray imaging device, for providing required dataconcerning blood flow through the artery and to provide indicationcorresponding with the precise position of the puncture in the bloodvessel. The transducer 80 may be fixedly nested within a seating of thetissue-confining device, e.g. by means of plunger 70 engaging with asuitable recess 82 formed on the transducer 80 which facilitatesattachment or detachment of plunger 70.

FIGS. 5A to 5G illustrate modifications of tissue-confining devicesaccording to the present invention. In FIG. 5A proximal plunger 88integrally extends from the attachment bracket 90, (attaching thetissue-confining device 94 to the free end 96 of the artery clampdevice-not shown). Here again, the axial displacement of the proximalplunger 88 may be adjusted and temporarily fixed by means of retentionnut 98. Other elements of the tissue-confining device 94 are similarwith those disclosed in connection with the embodiment of FIG. 2.

The tissue-confining device 100 illustrated in FIG. 5B is principallysimilar to that disclosed in FIG. 5A wherein the proximal plunger 102integrally extends from bracket 104 rather than being integral with thetissue-confining device. A difference however resides in that thelongitudinally extending bars 108 and 110 of the tissue-confining deviceare connected to one another only by a proximal connecting bar 112,leaving an opening 116 at the distal end, for receiving therethrough aguide sheath (as exemplified in FIG. 5D).

Similarly, the embodiment of FIG. 5C illustrates a tissue-confiningdevice 120 formed with a distal opening 122. However, in this embodimentthe proximal plunger 124 is integral with the proximal connecting bar126 rather than with the bracket connecting to the free end of theartery clamp device as in FIG. 5B.

In FIG. 5D, the tissue-confining device 132 has a distal opening 134, asin FIGS. 5B and 5C, adapted for placing the tissue-confining device 132over a guide sheath 136 such that the guide sheath extends within theopen area 138 of the tissue-confining device. This allows forpositioning of the distal plunger 139, which is a rectangular element,directly above the puncture in the blood vessel.

The distal plunger 139 of FIG. 5D functions similarly to that disclosedin connection with FIG. 2, with the difference that it cannot be fixedat different axial positions but rather is pressured by the finger tipsof an operator to the required degree of pressure.

FIGS. 5D and 5F illustrate embodiments of tissue-confining devices inwhich the guide sheath extends within the gap, whilst FIG. 5Eillustrates a tissue-confining device in which the guide sheath extendsbehind (i.e. downstream) the distal connecting bar of thetissue-confining device.

In order to increase the contact area of the tissue-confining devicewith the tissue in the vicinity of the blood vessel, the proximal end oftissue-confining device 146 in FIG. 5E comprises two proximal extensions148 and 150, which result in an open area 152 formed therebetween.

FIGS. 5F and 5G illustrate a modification of a tissue-confining devicegenerally designated 160 in which a front bar 162 is formed with anopening 164 of width corresponding with the width of a guide sheath 168,or greater.

The proximal plunger 170 is integral with the proximal connecting bar172. The distal plunger 176 is slidably received on a rod 178 which inturn is pivotally mounted at 182 to the front bar 162, whereby it ispivotal between an open position (FIG. 5F) and a closed, operativeposition (FIG. 5G).

The open position of FIG. 5F is useful for removing the guide sheath 168prior to withdrawal thereof from the limb (not shown). After withdrawalof the guide sheath 168 the distal plunger 176 may be used for applyingdirect axial pressure over, the puncture site.

The procedure in accordance with the present invention is such thatafter completing the medical procedure performed by a stent (introducedthrough the guide sheath), the adjustable artery clamp device 22 (FIG.3) is placed such that the base plate 28 bears under the limb L, and arm30 is then adjusted so that the distal and proximal plungers may applydirect axial pressure above the blood vessel BV (an artery in thepresent case) through which the guide sheath GT extends. The axialpressure applied by a plunger, or alternatively by a tissue-confiningdevice, is monitored by pressure monitor 38. The arrangement is suchthat a tissue portion is compressed by the side bars 42 and 44 of thetissue-confining device, and adjoining tissue projects into the openarea between the longitudinally extending bars, as illustrated in FIG.3. As a result, the tissue-confining device is positioned and fixatedrelative to the blood vessel.

Then, the proximal plunger 60, extending upstream of the puncture formedby the guide sheath GT, is lowered so as to cause partial occlusionknown as stenosis) at the rate of 50% or more. This situation eliminatesthe vibrating/pulsating effect of the walls of the artery, resulting ina lack of systole and diastole, as well as in reduced blood flowvelocity at the puncture site. It is well known that in the absence ofsuch vibrations/pulsations improved coagulation occurs, as the bloodplatelets accumulate easier at the puncture of the blood vessel,reducing the coagulation (hemostasis) time. The extent to which theblood vessel is occluded can be monitored by a suitable transducer asillustrated in FIG. 4. This may be carried out by measuring the bloodflow pressure or velocity, or by measuring the pulses of blood flowwithin a blood vessel distal to the puncture site.

At the next stage, the guide sheath GT may be withdrawn, with theproximal plunger still applying axial pressure upstream, maintaining lowblood flow and pressure downstream from the puncture site.

In accordance with another embodiment, where the tissue-confining devicecomprises also a distal plunger (as in the exemplified embodimentshereinabove), upon withdrawal of the guide sheath GT, the distal plunger(not seen in FIG. 3) is axially lowered directly above the puncture atthe blood vessel, improving and increasing speed of sealing of thepuncture by coagulation with respect to prior art puncture sealingdevices. Such pressure may be applied for as long as may be requiredfrom several minutes to as much as an hour or so. At any point of time,the transducer may be placed at the tissue-confining device forobtaining information regarding blood flow within the blood vessel atthe puncture site.

In FIGS. 6A and 6B, an additional embodiment of a tissue-confiningdevice in accordance with the invention is illustrated, generallydesignated 190, which differs from the previous embodiments in that theproximal plunger is fitted on a bar 198 which is slidingly received, bya dovetail arrangement, to a corresponding groove 200 of the bracket202, whereby the proximal plunger is longitudinally displaceable withrespect to the tissue-confining device 190, to allow for adjusting thelocation of the pressure point being applied thereby on the blood vessel(not shown). Similarly, a distal plunger 206 is provided, which ismounted on a bar 208 slidingly received, by a dovetail arrangement, to acorresponding groove 210 of the bracket 202, such that the distalplunger 206 is longitudinally displaceable with respect to thetissue-confining device 190, to allow for adjusting the location of thepressure point being applied thereby on the blood vessel (not shown).

Further illustrated in FIGS. 6A and 6B is a sealing plug support device218 adapted for positioning and supporting a sealing plug pusher member250 (illustrated in more detail in FIG. 7B), comprising a support sleeve222 mounted on a screw-type rod 224, which in turn is pivotallyconnected to the tissue-confining device 190 at 228. The sealing plugsupport device 218 facilitates supporting the pusher member 250 at adesired angular position and for axial displacement thereof by means ofthe threaded rod 224. The pusher member may be integral with the sealingplug.

In accordance with still an embodiment of the invention, a sealing plug240 (FIGS. 7A and 7B) may be used in conjunction with the apparatusaccording to the invention. Sealing plug 240 is a tubular body formed ata top end thereof with a sealing portion which is a pre-slottedresilient membrane 244, and having a truncated bottom wall 246,corresponding with a typical angle of insertion of the guide sheath (notshown). The body and the pre-slotted resilient membrane are sized so asto facilitate sliding thereof over an guide sheath. A pusher member 250(FIG. 7B) is attached to the sealing plug 240 sized for sliding over theguide tube GT (guide sheath) so as to facilitate withdrawal of the guidesheath therethrough.

Prior to withdrawal of the guide tube GT, the punctured sealing plug 240(FIG. 7A) is slidingly displaced along the guide sheath by means of thedispensing and guide tube 250 until a bottom surface 246 of the sealingplug 240 engages the blood vessel at the site of the puncture, such thatupon withdrawal of the guide sheath through the sealing plug, thepre-slotted resilient membrane spontaneously seals and the surface 246applies direct pressure over the puncture. After a while, the sealingplug 240 is removed by the aid of a dispensing tube 250 and then,further axial pressure may be applied by the distal plunger as discussedhereinabove. The hemostatis time may be further reduced by applying ahemostatic sealant, e.g. biodegradable materials, such as collagen,gelatin, fibrinogene, oxidized cellulose, hyaluronic acid, andcrosslinked dextrans, onto the sealing plug. Alternatively, the sealingplug may be made from a biodegradable material, and therefore may remainat the arterial puncture site while continuing to apply pressurethereat.

FIGS. 8-14 illustrate another embodiment of the invention wherein thedistal and proximal plungers apply pressure on a blood vessel byhydraulic means, in order to further reduce the hemostasis time, inaccordance with the present invention. Although the followingdescription relates to a hydraulic means for applying pressure onto ablood vessel, it will be appreciated that the apparatus can be similarlyemployed for applying pressure by pneumatic means, and any referencehereinafter to “hydraulic fluid” is also applicable to air, or any othercompressible fluid.

As shown in FIG. 8, the artery clamp device, designated generally as300, comprises axially displaceable distal plunger 330, proximal plunger360, and an angularly displaceable pad 310 connected to each of thedistal and proximal plungers. A hydraulic circuit comprising mechanicalactuator 285, cylinder 290 in which hydraulic fluid is pressurized, e.g.ranging from 10 to 40 psi, conduit 325 for the hydraulic fluid,manometer 350 for indicating the level of applied pressure on the tissueand junction 335, by which cylinder 290, conduit 325 and manometer 350are in fluid communication with one another, are provided with each ofthe distal plunger 330 and proximal plunger 360.

Adapter 370 facilitates positioning of plungers 330 and 360. Distalplunger 330 and proximal plunger 360 are longitudinally displaceable bymeans of a corresponding slider 318 of rectangular cross section, whichis slidingly received, by a dovetail arrangement, within a correspondinggroove 319 formed within adapter 370. A corresponding leg 315 connectseach of the plungers 330 and 360 to a corresponding slider 318. Axialpositioning of adapter 370, and consequently of plungers 330 and 360prior to being repositioned by means of hydraulic fluid, relative tobase plate 390 is effected by lowering or raising arcuate arms 380received in the top of adapter 370. After displacing adapter 370 to adesired axial position, lock screw 387 secures legs 385 of correspondingarcuate arms 380 to socket 386, which is perpendicular to base plate390, as shown in FIG. 9.

Adapter 370 is also adapted to receive a tissue-confining device.Various configurations of tissue-confining devices may be employed, suchas devices 410A-C, as illustrated in FIGS. 10A-C, respectively. Eachtissue-confining device is provided with a pair of connectors 420, whichare integrally formed therewith in such a way, e.g. with a 90-degreeelbow, that each connector is spaced from the longitudinally extendingbar 425 of the tissue-confining device positioned adjacent to theadapter, and is therefore engageable with the adapter, e.g. by apressure fit, at the bottom thereof, without interfering with the axialpressure applied by the longitudinally extending bars. Accordingly, theaxial position of adapter 370 relative to base plate 390 during apuncture sealing procedure is preferably such that a selectedtissue-confining device will apply axial pressure to the underlyingtissue.

Referring now to FIGS. 10A-C, the distance between the twolongitudinally extending bars 425 of each tissue-confining device, e.g.ranging from 5-40 mm, is selected so that the transversal spacingbetween an artery, within which a catheter was guided during a recentsurgical procedure, and each bar 425 ranges from 1-3 cm. With such atransversal spacing, the two bars 425, which are immobilized while beingin pressing engagement with tissue at the point of resistance of saidtissue and may be supported by a bone in the vicinity of the artery,when a tissue-confining device applies axial pressure to the underlyingtissue, the artery is fixated by compressed tissue that is interposedbetween the artery and each bar 425. Base plate 390 (FIG. 8) placedunderneath a patient further supports and stabilizes thetissue-confining device.

In the shown configuration of a tissue-confining device, each connectingbar 427 which connects the two longitudinally extending bars 425,whether at the distal or proximal end thereof, is provided with acurvature with respect to a vertical plane, such that the connecting baris axially separated from a longitudinally extending bar. This curvatureretains mechanical integrity of the tissue-confining device withoutcompressing the artery, since the connecting bar is not in contact withthe tissue. In FIG. 10A, two connecting bars 427 are employed, while inFIG. 10B only one is used, with an opening 428 being formed at theproximal end of tissue-confining device 410B. Opening 428 advantageouslyallows for the placement and repositioning of an imaging device. In FIG.10C, the distal end of tissue-confining device 410C is provided with twoends 429, which are in a spaced, opposed relation with one another,having a curvature with respect to a vertical plane.

After inserting a desired tissue-confining device and axially andlongitudinally positioning plungers 330 and 360, pressurized hydraulicfluid may be delivered to the plungers, for the lowering of the latteron selected locations along an artery, e.g. the femoral artery.Hydraulic fluid is introduced to cylinder 290 via an opened stopcock(not shown), or via any other suitable valve in communication with port430 of junction 335 (FIG. 11A), and is pressurized within the cylinder,after the valve is closed, by advancing actuator 285 in the direction ofmanometer 350. As the pressure of hydraulic fluid rises within cylinder290, fluid is delivered to the corresponding plunger, after flowingthrough conduit 325, due to the pressure differential that initiallyexists between the cylinder and the corresponding plunger, whereupon thecorresponding plunger contacts the underlying tissue. Due to thereactive force applied by the tissue onto the plunger, the pressure ofthe hydraulic fluid rapidly increases to a level ranging from 10 to 40psi. The pressure applied by a plunger onto the tissue, which isindicated by manometer 350, is controllable, as will be describedhereinafter. Upon achieving a desired applied pressure, lock screw 440secures actuator 285 to a fixed position (FIGS. 11A-B). The hydraulicfluid is self-contained in a closed hydraulic path between a plunger anda corresponding cylinder 290, and therefore may be drawn from a plungerto the corresponding cylinder 290 upon conclusion of the puncturesealing procedure by retracting actuator 285 and reducing the pressureof the hydraulic fluid by increasing the volume of cylinder 290.

As shown in FIGS. 11A and 11B, actuator 285 is cylindrical and is formedwith threading. The external threading of the actuator facilitates thesecuring of lock screw 440, which protrudes from lip 292 of cylinder290, to actuator 285, i.e. as a result of the pressing of pin 443 of thelock screw to a flank 287 located between adjacent threads 288. If theactuator were not secured to the cylinder, the actuator would berearwardly displaced and consequently released from the cylinder, due toan increase in pressure within the corresponding plunger. In addition toproviding a securing means, the external threading also provides a meansof displacing the actuator within cylinder 290, in order to pressurizethe hydraulic fluid. By securing lock screw 440 at a moderate pressureto actuator 285, the actuator is prevented from being rearwardlydisplaced, yet the actuator is not immobilized and may be rotated withincylinder 290. As actuator 285 is rotated, pin 443 of the lock screwcontinuously contacts the flank 287 between a changing pair of adjacentthreads 288. If so desired, pin 443 may be lowered below the height ofthreads 288 without being in contact with flank 287. Rearward movementof the actuator is prevented due to the contact of pin 443 with a thread288, while its rotation is made possible through a path between adjacentthreads. Consequently, the pressure applied by a plunger is controllableby gradually advancing or retracting the actuator when the plunger is incontact with the underlying tissue, in response to the pressureindicated by the manometer. For example, the pressure applied by theproximal cylinder is generally increased until a reduction in blood flowvelocity is noticeable or partial occlusion within the blood vessel isachieved.

By employing a three-way or four-way stopcock, the pressurized hydraulicfluid may be isolated from junction 335 after having been delivered to aplunger. It will therefore be appreciated that one actuator 285 and onecylinder 290 may be used for both the distal and proximal plungers. Thatis, the actuator and cylinder may be removed from a junction 335 afterhydraulic fluid has been delivered to the proximal plunger, for example,and isolated from its corresponding junction, and then the same actuatorand cylinder may be used for delivering hydraulic fluid to the distalplunger.

FIG. 12 illustrates a typical positioning of tissue-confining device 410relative to a puncture site 480 of the femoral artery. As previouslymentioned, precise positioning of a tissue-confining device is carriedout in conjunction with the data transmitted by a duplex ultrasound,Doppler, or any other imaging device, in order to determine the exactanatomical location of the femoral artery and the arterial puncturesite, as well as the blood flow velocity, so that an optimal magnitudeof axial pressure may be applied to the tissue. After determining theexact location of the artery and arterial puncture site,tissue-confining device 410 is transversally positioned such that theaxis of the femoral artery 490 is parallel to, interposed between, andlocated below, the two longitudinally extending bars 425 of thetissue-confining device. Furthermore, tissue-confining device 410 islongitudinally positioned so that arterial puncture site 480 is locatedat substantially the transversal centerline of bars 425. Pressureapplied to the underlying tissue 485 by a correctly positionedtissue-confining device results in fixation of the two bars 425 relativeto artery 490 and reduces the tissue thickness between the skin and theartery. Consequently the pressure applied by distal plunger 330 andproximal plunger 360 to the artery may be effected more rapidly andaccurately than with prior art puncture sealing devices, resulting in asignificant reduction of hemostatic time. Furthermore, pressure appliedto the tissue by a tissue-confining device decreases the angle of awound canal, which is formed by the penetration of guide sheath 495 intotissue 485 for the purpose of cardiac catheterization, with respect to ahorizontal plane, thereby facilitating the sealing of the wound canal.

Proximal plunger 360 is adapted to apply a sufficient axial pressure toartery 490, at a location of 1 to 5 cm proximal to arterial puncturesite 480, in order to induce moderate stenosis, severe stenosis or totalocclusion within the artery. It will be appreciated that minimal bloodflow through artery 490 is retained so as to prevent premature clotdisintegration, and consequently to reduce risks of bleeding,pseudoaneurysm and hematoma. The partial retraction of guide sheath 495,concurrently with the lowering of proximal plunger 360, initiates bloodflow through the wound canal. A sufficient interruption of femoralarterial flow may be ascertained by imaging means, or alternatively, bymeasuring pedal or politeal pulses, at a location distal to arterialpuncture site 480, or by visually determining lack of blood seepage fromthe wound canal. The proximal plunger is preferably lowered onto theselected pressure point in a single continuous motion, so as to minimizepatient discomfort.

If pad 310 of the proximal plunger is not directly located above artery490 at such a distance from arterial puncture site 480, followinglongitudinal displacement of slider 318, it may be rotated to ensureaxial compression directly on the correct location of the artery. Asshown more clearly in FIGS. 13A and 13B, plunger 360 is rotatable withinits casing 362. Since elliptical upper surface 312 of pad 310 isconnected to flange 363 of the plunger by a press fit as shown, oralternatively may be integrally formed therewith, pad 310 is alsorotatable about the axis of plunger 360. Therefore the pad serves as anangular adjusting means. If so desired, the proximal plunger mayterminate with a concentric, circular pad 314 as shown in FIG. 14.Distal plunger 360 is provided with a similar pad arrangement.

Distal plunger 330 is adapted to apply axial pressure directly overarterial puncture site 480. Since the distal plunger may beadvantageously longitudinally and axially positioned in a speedy manner,a physician performing the puncture sealing procedure can apply pressureto arterial puncture site 480 within 3 minutes, for example. Thepressure of the hydraulic fluid delivered to the distal plunger may belower than that delivered to the proximal plunger, a level ranging e.g.from 5 to 20 psi. After the distal plunger begins to apply pressure, thepressure applied by the proximal plunger may be gradually decreased insmall increments, in order to prevent premature clot disintegration. Byapplying a compressive force at two pressure points, rather than at onepressure point, the pressure applied by each of the proximal and distalplungers is therefore reduced.

Although the aforementioned description related to the coagulation of apuncture site produced within an artery, and particularly the femoralartery, it will be appreciated that the use of the present invention issuitable for any blood vessel. Accordingly, the present invention isalso applicable for the treatment of a pseudoaneurysm and the absorptionthereof into an adjacent blood vessel, by the application of an axialforce by the proximal plunger proximally to a puncture site and by thedistal plunger on the path of blood communication between the artery andthe hematoma (commonly referred to as the pseudoaneurysm neck). For apseudoaneurysm neck having a length less than 5 mm, the pressure appliedby the distal plunger thereon usually suffices to prevent blood inflowinto the pseudoaneurysm. However, if the length of the pseudoaneurysmneck is greater than 5 mm, supplementary axial pressure applied to thepseudoaneurysm neck is provided by a longitudinally extending bar of thetissue-confining device. A clot may therefore be formed in thepseudoaneurysm in approximately 15 minutes, in contrast with a durationof approximately 1.5 hours that is needed with prior art pseudoaneurysmtreatment methods whereby pressure is applied directly onto the puncturesite.

It will be appreciated that the distal and proximal plungers may besimilarly electrically actuated, e.g. while in communication with acontroller, as is well known to those skilled in the art, in accordancewith the aforementioned puncture sealing method

Another embodiment of the invention incorporates a hydraulicallydisplaceable sealing plug for augmenting the aforementioned puncturesealing method, particularly suitable for punctures caused by largesheaths of greater than 8 French (an inner diameter of greater than 2.64mm). Once again, the following description relates to hydraulic means,but it will be appreciated that pneumatic and electric means may also beemployed to displace the sealing plug.

As shown in FIG. 15A, sealing plug 540 is slidingly displaceable overguide sheath 495. A guide sheath is typically introduced into an artery,as shown in FIG. 12, so that a catheter may be inserted within thesheath and guided within the artery, in close proximity of the bodilytissue of interest for examination or treatment. Sliding plug 540 isengageable with the bottom of telescoping plunger 550, e.g. by means ofthreading. Upon operator input, plunger 550 telescopes, as shown in FIG.15B, and plug 540 is thereby downwardly displaced to the arterialpuncture site, at which the plug applies pressure and helps to seal thepuncture site.

As shown in FIG. 16, a third hydraulic circuit, which is designatedgenerally by 530, in addition to hydraulic circuits 510 and 520 for thedistal and proximal plungers, respectively, is adapted to displacesliding plug 540 along sheath 495. In order to provide the reactiveforce needed to generate increased pressure within telescoping plunger550, sheath 495 is supported, e.g. by clips, onto connecting bar 427,located at the distal end of tissue-confining device 410B.

If so desired, plug 540 may be slidingly displaced along sheath 495 bymechanical means, as shown in FIG. 17.

While some embodiments of the invention have been described by way ofillustration, it will be apparent that the invention can be carried intopractice with many modifications, variations and adaptations, and withthe use of numerous equivalents or alternative solutions that are withinthe scope of persons skilled in the art, without departing from thespirit of the invention or exceeding the scope of the claims.

1. An apparatus for sealing a puncture in a blood vessel comprising a tissue-confining device longitudinally extending between a proximal end and a distal end; a proximal plunger positioned adjacent to said proximal end, for adjustably applying axial pressure on the blood vessel; said tissue-confining device being connected to an adjustable artery clamp for adjustably applying pressure in an axial direction.
 2. The apparatus according to claim 1, further comprising a distal plunger, said distal plunger adapted for applying axial pressure onto the blood vessel, essentially above the puncture.
 3. The apparatus according to claim 1, wherein the tissue-confining device comprises two parallel, longitudinally extending bars, interconnected at or adjacent their respective proximal and/or distal ends by arcuate connecting members.
 4. The apparatus according to claim 1, wherein the tissue-confining device is pivotally connected to the artery clamp.
 5. The apparatus according to claim 1, wherein the tissue-confining device is releasable from the artery clamp device.
 6. The apparatus according to claim 2, wherein the distal plunger is pivotally mounted on a pivotally displaceable bracket secured to the tissue-confining device.
 7. The apparatus according to claim 1, wherein the tissue-confining device further comprises a seating for removably fixing thereto a transducer of an imaging device.
 8. The apparatus according to claim 1, further comprising a pressure indicating means for indicating the axial pressure applied to tissue.
 9. The apparatus according to claim 3, wherein one of the bars is formed with an opening for removing therethrough a guide sheath.
 10. The apparatus according to claim 1, wherein the proximal plunger extends from the artery clamp device.
 11. The apparatus according to claim 1, wherein the proximal plunger extends from the tissue-confining device.
 12. The apparatus according to claim 2, wherein the proximal and/or distal plunger is axially displaceable.
 13. The apparatus according to claim 2, wherein the proximal plunger and/or the distal plunger is longitudinally slidingly displaceable.
 14. The apparatus according to claim 1, further comprising at a distal side of the tissue-confining device, a sealing plug support device for positioning and supporting a sealing plug pusher member.
 15. The apparatus according to claim 14, wherein the sealing plug comprises a blood vessel engaging portion for bearing against the boundaries of the puncture, and a sealing portion slidably received over a guide sheath; said sealing portion being spontaneously sealable upon withdrawal of the guide sheath; the sealing plug being displaceable by a pusher member.
 16. The sealing plug according to claim 15, wherein the pusher member is attached to the sealing plug to facilitate withdrawal thereof.
 17. The sealing device according to claim 15, wherein the sealing portion is a pre-slotted resilient membrane.
 18. The apparatus according to claim 3, wherein a connecting member is adapted for supporting a telescoping plunger, a sealing plug connected to the bottom of said telescoping plunger being slidable about the outer wall of a sheath insertable within a puncture site of a blood vessel.
 19. The apparatus according to claim 2, further comprising means for adjusting the angular orientation, with respect to the artery clamp, of a point from which pressure is applied to the blood vessel.
 20. The apparatus according to claim 1, wherein axial pressure is applied by means selected from the group of mechanical means, hydraulic means, pneumatic means and electrical means.
 21. The apparatus according to claim 20, wherein axial pressure is generated by means of a fluid circuit comprising an actuator, a cylinder in which fluid is pressurized, a conduit for said fluid, and a junction by which said cylinder and said conduit are in fluid communication with one another, fluid being flowable within said fluid circuit to or from a plunger.
 22. The apparatus according to claim 21, wherein the axial pressure is adjustable by means of the actuator.
 23. The apparatus according to claim 21, wherein the junction is in fluid communication with a valve through which fluid is introduced to the fluid circuit and with a manometer for indicating the pressure being applied to tissue or to a blood vessel, said valve being adapted for isolating the fluid from the cylinder, the actuator and cylinder thereby being removable from the fluid circuit, said removable actuator and cylinder being adapted for actuating both the proximal and distal plungers.
 24. A tissue-confining device for sealing a puncture in a blood vessel comprising two parallel, longitudinally extending bars, interconnected at or adjacent their respective proximal and/or distal ends by arcuate connecting members, said tissue-confining device suitable for compressing tissue in the vicinity of a punctured blood vessel and for being connected to an adjustable artery clamp, which is adapted for adjustably applying pressure in an axial direction onto a blood vessel.
 25. The tissue-confining device according to claim 24, further comprising a distal plunger, said distal plunger adapted for applying axial pressure essentially above the puncture at the blood vessel.
 26. A method for sealing a puncture in a blood vessel caused by a guide sheath, said method comprising the following steps: a) confining the blood vessel and fixedly positioning it; b) applying an axial force on the blood vessel upstream of the puncture, so as to cause partial occlusion thereof; and c) withdrawing the guide sheath.
 27. A method for sealing a puncture in a blood vessel caused by a guide sheath, said method comprising the following steps: a) axially positioning over the blood vessel, at the vicinity of the puncture, an apparatus comprising a tissue-confining device, a proximal plunger positioned upstream of the puncture, said tissue-confining device connected to an adjustable artery clamp device; b) adjustably applying an axial force at the vicinity of the puncture by said artery clamp device, to thereby confine the blood vessel; c) adjustably applying axial pressure on the blood vessel by said proximal plunger, to reduce the blood pressure and blood flow in the blood vessel; and d) withdrawing the guide sheath.
 28. The method according to claim 27, wherein at least step c) is carried out while monitoring pressure in the blood vessel.
 29. The method according to claim 26, wherein axial pressure is further applied by a distal plunger, directly over the puncture.
 30. The method according to claim 26, comprising a further step wherein a puncture sealing plug is introduced and applied over the puncture.
 31. The method according to claim 30, wherein the sealing plug is slid over the guide sheath, downwardly displaced and placed in pressing engagement with an arterial puncture.
 32. An The method according to claim 30, wherein the sealing plug is not removed from the puncture.
 33. A method for treating a pseudoaneurysm, said method comprising the following steps: a) detecting a pseudoaneurysm and a pseudoaneurysm neck between an artery and said pseudoaneurysm; b) confining the pseudoaneurysm or pseudoaneurysm neck; c) fixedly positioning said pseudoaneurysm or pseudoaneurysm neck; d) applying a controllable axial force on said artery upstream to a puncture which resulted in said pseudoaneurysm, so as to cause partial or total occlusion within said artery ; and e) applying a controllable axial force on said pseudoaneurysm neck, thereby inducing a blood clot within said pseudoaneurysm.
 34. An apparatus for controllably applying pressure onto a blood vessel, comprising: a) a tissue-confining device for compressing tissue in the vicinity of a punctured blood vessel which longitudinally extends between a proximal end and a distal end; b) at least one axially and longitudinally displaceable plunger for applying pressure onto said blood vessel; c) means for positioning said at least one plunger to a first location above a skin target and directly over said blood vessel; d) means for generating a controllable force; and e) means for transmitting said controllable force to said at least one plunger in such a way that said at least one plunger is axially displaceable from said first location to a second location in contact with said skin target and directly above said blood vessel, and that a controllable and known pressure is applied by said at least one plunger onto said skin target, said pressure being controllable to such a degree so as to reduce blood flow velocity within said blood vessel.
 35. The apparatus according to claim 34, wherein the means of generating a controllable force is selected from the group of hydraulic means, pneumatic means and electric means. 